NCT00217776

Brief Summary

This random trial will deploy 2 interventions and a control group with eleven and twelve year old, low income, African American students in middle schools in Detroit, MI. The goals are to determine if 1) a self-management program focused on pre-teen capabilities designed for middle schools produces desired outcomes, and 2) if the program, enhanced by a peer component, improves upon outcomes. Outcomes of interest are symptom experience, quality of life, self-management, and school grades.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,292

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

5.9 years

First QC Date

September 19, 2005

Last Update Submit

January 16, 2013

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Health Care Use Data

    health care use will be self reported in the telephone interviews with parents at baseline, 12 months and 24 months.

    At Baseline, 12 month and 24 months

Study Arms (3)

Open Airways Educational Intervention

ACTIVE COMPARATOR

Children in this arm will receive the Open Airways educational program which is an evidenced based asthma educational program for children, developed by the investigator.

Behavioral: Open Airways Educational Intervention

Open Airways and Peer Asthma Action Intervention Education

ACTIVE COMPARATOR

Children in this arm will receive BOTH the Open Airways asthma education program and the Peer Asthma Action education program.

Behavioral: Open Airways Educational InterventionBehavioral: Peer Asthma Action Educational Intervention

Control Arm

NO INTERVENTION

Children in the Control Arm will be interviewed in person at baseline, 12 month and 24 months.

Interventions

Open Airways Educational InterventionBEHAVIORAL
Also known as: A 6 week asthma educational self management program for middle school students.
Open Airways Educational InterventionOpen Airways and Peer Asthma Action Intervention Education
Peer Asthma Action Educational InterventionBEHAVIORAL
Also known as: Peer Asthma Action Educational Intervention is a peer led training program for children in multiple grades teaching them about asthma and asthma management.
Open Airways and Peer Asthma Action Intervention Education

Eligibility Criteria

Age11 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Children identified for this research will be a sample of 6th grade students enrolled in 19 public middle schools in Detroit, Michigan who meet the following criteria: 1) attend a participating school, 2) be 11-12 years old at the time of entry into the study (enrolled in 6th grade) and 3) based on NAEPP guidelines (a) have a diagnosis of asthma and have active asthma symptoms and/or have received a prescription for asthma medications in the last year, or (b) report the presence of 3 of 5 non-exercise related asthma symptoms in the last year on five or more occasions, or (c) report two or more exercise related asthma symptoms in the past year on five or more occasions, or (d) have a severity classification of persistent disease (mild, moderate, severe) based on night time questions, and 4) have returned a signed parental consent form.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Noreen M. Clark, PhD

    University of Michigan School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

February 1, 2003

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 17, 2013

Record last verified: 2013-01